FDA.reportPublic FDA data

hydroxyzine pamoate

Product NDC
14539-675
11-digit product format
145390675
Labeler code
14539
Product ID
14539-675_843627c2-146c-4715-b5b5-8c5c80a8f615
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
hydroxyzine pamoate
Dosage form
CAPSULE
Route
ORAL
Labeler
Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
Application
ANDA201507
Marketing category
ANDA
Marketing start
2013-06-03
Substance
HYDROXYZINE PAMOATE
Active strength
50 mg/1
Pharmacologic classes
Antihistamine [EPC], Histamine Receptor Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
hydroxyzine pamoate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HYDROXYZINE PAMOATE50 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiM20215MUFR
Rxcui995253, 995278

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
57311cfb-679a-da1a-b70c-8757f7fc431aProduct name420250516
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
aa1826f4-97c1-4705-bdf0-3bc7d234e618Product name220190618
75cb12ee-8eb2-4f1a-a332-5743a5d0da41Product name120151110
3ca5f78b-43dc-30fe-8014-55b922af52b3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
14539-675-01hydroxyzine pamoate100 in 1 CONTAINERCAPSULE1006
14539-675-05hydroxyzine pamoate500 in 1 CONTAINERCAPSULE5006

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
14539-675-01EA - Each14539-6756f8d8e89-3e6a-4722-bc95-f280a0dac9f112019-07-02
14539-675-05EA - Each14539-675a8fdaf47-c495-43e6-b285-16efa9d3827112019-07-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
14539-675HYDROXYZINE PAMOATE CAPSULE [HERITAGE PHARMACEUTICALS INC. D/B/A AVET PHARMACEUTICALS INC.]4Current NDC, Legacy NDC, 2 package rows20240203_734d32c8-38d3-430f-a2b3-539e03a3687a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
995278hydrOXYzine pamoate 50 MG Oral CapsulePSN74bf62c3-b444-46dc-aab6-af74b101a68a10
995278hydroxyzine pamoate 50 MG Oral CapsuleSCD74bf62c3-b444-46dc-aab6-af74b101a68a10
995278hydroxyzine pamoate 50 MG (hydroxyzine pamoate 85.2 MG eqv to hydroxyzine HCl 50 MG) Oral CapsuleSY74bf62c3-b444-46dc-aab6-af74b101a68a10
995253hydrOXYzine pamoate 25 MG Oral CapsulePSN734d32c8-38d3-430f-a2b3-539e03a3687a6
995278hydrOXYzine pamoate 50 MG Oral CapsulePSNdde576e9-fb6b-40d2-a81f-ebb8656c4c9c6
995278hydrOXYzine pamoate 50 MG Oral CapsulePSN734d32c8-38d3-430f-a2b3-539e03a3687a6
995253hydroxyzine pamoate 25 MG Oral CapsuleSCD734d32c8-38d3-430f-a2b3-539e03a3687a6
995278hydroxyzine pamoate 50 MG Oral CapsuleSCDdde576e9-fb6b-40d2-a81f-ebb8656c4c9c6
995278hydroxyzine pamoate 50 MG Oral CapsuleSCD734d32c8-38d3-430f-a2b3-539e03a3687a6
995278hydroxyzine pamoate 50 MG (hydroxyzine pamoate 85.2 MG eqv to hydroxyzine HCl 50 MG) Oral CapsuleSY734d32c8-38d3-430f-a2b3-539e03a3687a6
995278hydroxyzine pamoate 50 MG (hydroxyzine pamoate 85.2 MG eqv to hydroxyzine HCl 50 MG) Oral CapsuleSYdde576e9-fb6b-40d2-a81f-ebb8656c4c9c6
995278hydrOXYzine pamoate 50 MG Oral CapsulePSN127617c2-9775-3859-e063-6394a90a77cd3
995278hydroxyzine pamoate 50 MG Oral CapsuleSCD127617c2-9775-3859-e063-6394a90a77cd3
995278hydroxyzine pamoate 50 MG (hydroxyzine pamoate 85.2 MG eqv to hydroxyzine HCl 50 MG) Oral CapsuleSY127617c2-9775-3859-e063-6394a90a77cd3
995253hydrOXYzine pamoate 25 MG Oral CapsulePSN240fd428-15af-e7d0-e063-6394a90acbc52
995278hydrOXYzine pamoate 50 MG Oral CapsulePSN240fd428-15af-e7d0-e063-6394a90acbc52
995278hydrOXYzine pamoate 50 MG Oral CapsulePSNc0f7f48d-e39c-4981-9c0e-5c2eccaba4242
995278hydrOXYzine pamoate 50 MG Oral CapsulePSNb903f7e1-250d-46d8-a1ec-3f1dabc597f12
995253hydroxyzine pamoate 25 MG Oral CapsuleSCD240fd428-15af-e7d0-e063-6394a90acbc52
995278hydroxyzine pamoate 50 MG Oral CapsuleSCD240fd428-15af-e7d0-e063-6394a90acbc52
995278hydroxyzine pamoate 50 MG Oral CapsuleSCDc0f7f48d-e39c-4981-9c0e-5c2eccaba4242
995278hydroxyzine pamoate 50 MG Oral CapsuleSCDb903f7e1-250d-46d8-a1ec-3f1dabc597f12
995278hydroxyzine pamoate 50 MG (hydroxyzine pamoate 85.2 MG eqv to hydroxyzine HCl 50 MG) Oral CapsuleSYb903f7e1-250d-46d8-a1ec-3f1dabc597f12
995278hydroxyzine pamoate 50 MG (hydroxyzine pamoate 85.2 MG eqv to hydroxyzine HCl 50 MG) Oral CapsuleSYc0f7f48d-e39c-4981-9c0e-5c2eccaba4242
995278hydroxyzine pamoate 50 MG (hydroxyzine pamoate 85.2 MG eqv to hydroxyzine HCl 50 MG) Oral CapsuleSY240fd428-15af-e7d0-e063-6394a90acbc52
995278hydrOXYzine pamoate 50 MG Oral CapsulePSN1302c511-eb25-5818-e063-6394a90a92251
995278hydroxyzine pamoate 50 MG Oral CapsuleSCD1302c511-eb25-5818-e063-6394a90a92251
995278hydroxyzine pamoate 50 MG (hydroxyzine pamoate 85.2 MG eqv to hydroxyzine HCl 50 MG) Oral CapsuleSY1302c511-eb25-5818-e063-6394a90a92251

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
14539-675-0114539067501100 CAPSULE in 1 CONTAINER (14539-675-01) 100 capsule2019-04-230000-00-00NoNoCurrent
14539-675-0514539067505500 CAPSULE in 1 CONTAINER (14539-675-05) 500 capsule2019-04-230000-00-00NoNoCurrent